ZIRCONIA CERAMIC FEMORAL HEAD

{0} K935921 NOV 28 1994 # SUMMARY OF SAFETY AND EFFECTIVENESS Smith & Nephew Richards Inc. is submitting a premarket notification for the Zirconia Ceramic Femoral Head. The device is identical to the zirconia ceramic femoral heads previously submitted by Smith & Nephew Richards to the FDA with the exception of a change in the manufacturing vendor. SA356207/1 55 {1} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service NOV 28 1994 Food and Drug Administration 1390 Piccard Drive Rockville MD 20850 Mr. Thomas L. Craig Director - Regulatory Affairs Smith & Nephew Richards, Inc. 1450 Brooks Road Memphis, Tennessee 38116 Re: K935921 Zirconia Ceramic Femoral Head Regulatory Class: II Product Code: LZO Dated: November 12, 1994 Received: November 17, 1994 Dear Mr. Craig: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). This decision is based upon the use of the AstroMet AmZirOx balls with the stems listed below: | Stem | 510(k) # | Stem Material | Material Standard | | --- | --- | --- | --- | | Bio-Fit | K854791 | CoCr | (ASTM F 75) | | Opti-Fix | K860635, R921400 | Ti-6Al-4V | (ISO 5832/III) | | Spectron | K823727, R823722 | CoCr | (ASTM F 799) | | HJD | K881117 | Ti-6Al-4V | (ISO 5932/III) | | Ti-Fit | K873797 | Ti-6Al-4V | (ISO 5832/III) | | Tri-Wedge (Hartford) | K870128, K921400 | Ti-6Al-4V | (ISO 5832/III) | | International Modular Hip System | K862225 K900628, K921400 | Ti-6Al-4V Ti-6Al-4V | (ISO 5832/III) (ISO 5832/III) | | Modular Hip System | K912593 | CoCr | (ASTM F 75) | | RMHS Monolithic | K923275 | Ti-6Al-4V | (ISO 5832/III) | You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitations: {2} Page 2 - Mr. Thomas L. Craig 1. The contraindications of the labeling must include: "The Zirconia Ceramic Head is contraindicated for use with any other than an UHMWPE cup or a metal backed UHMWPE cup." 2. The Warnings and Precautions of the labeling must include: "The Zirconia Ceramic Head is composed of a new ceramic material with limited clinical history. Although mechanical testing demonstrates that, when used with polyethylene acetabular cups, the partially stabilized Zirconium ball produces a relatively low amount of particulates, the total amount of particulate remains undetermined. Because of the limited clinical and preclinical experience, the long term biological effects of these particulates are unknown. 3. The stems identified above are labeled for use with the following Zirconia Ceramic Heads: | Cat.No. | DiameterNeck Length | | --- | --- | | 42-7814 | 32mm Short | | 42-7815 | 32mm Standard | | 42-7816 | 32mm Long | | 42-7817 | 32mm X-Long | | 42-7818 | 28mm Standard | | 42-7819 | 28mm Long | | 42-7820 | 28mm X-Long | | 42-7821 | 26mm Long | | 42-7822 | 26mm X-Long | The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Performance Standards) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations. {3} Page 3 - Mr. Thomas L. Craig This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a pre-amendments device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-300) at (301) 594-4639. Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597. Sincerely yours, Paul R. Beninger, M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health 3